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Iressa Case Control Study in Japan

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00252759
First received: November 14, 2005
Last updated: January 27, 2011
Last verified: January 2011
History of Changes
  Purpose

The purposes of this study are:

  • To estimate the relative risk of ILD in advanced/recurrence NSCLC patients treated with gefitinib as compared to other chemotherapy treatment, and to assess the risk factors for ILD in advanced/recurrence NSCLC patients undergoing treatment
  • To provide an estimate of the incidence of ILD in a group of advanced/recurrence NSCLC patients undergoing treatment

Condition Phase
Non-small Cell Lung Cancer
 Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: A Nested Case-control Study to Determine the Relative Risk of and Risk Factors for Interstitial Lung Disease in a Cohort of NSCLC Patients Treated With and Without Gefitinib

Resource links provided by NLM:

Drug Information available for: Gefitinib
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Estimated Enrollment: 6000
Study Start Date: November 2003
Study Completion Date: February 2006
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients

Criteria

Inclusion Criteria:

  • Advanced/recurrence NSCLC patients who have had one or more chemotherapy regimens.
  • Patients who are to be treated with gefitinib or chemotherapy
  • Cohort: All advanced/recurrence NSCLC patients participating in this post-marketing clinical study

Exclusion Criteria:

  • Patients judged by the investigator(s) to have ILD (provisional cases) among those registered in the cohort OR Randomly selected patients without ILD (controls) for each provisional case
  • Case-control study: Patients enrolled in the case-control study; all consenting patients with ILD as cases and approximately 4 times as many consenting patients without ILD as controls randomly selected from the cohort
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00252759

Locations
Japan
Research Site
Nagoya, Aichi, Japan
Research Site
Okazaki, Aichi, Japan
Research Site
Toyoake, Aichi, Japan
Research Site
Imba-gun, Chiba, Japan
Research Site
Kashiwa, Chiba, Japan
Research Site
Matsuyama, Ehime, Japan
Research Site
Kitakyushu, Fukuoka, Japan
Research Site
Asahikawa, Hokkaido, Japan
Research Site
Sapporo, Hokkaido, Japan
Research Site
Akashi, Hyogo, Japan
Research Site
Kobe, Hyogo, Japan
Research Site
Kanazawa, Ishikawa, Japan
Research Site
Isehara, Kanagawa, Japan
Research Site
Sagamihara, Kanagawa, Japan
Research Site
Yokohama, Kanagawa, Japan
Research Site
Sendai, Miyagi, Japan
Research Site
Omura, Nagasaki, Japan
Research Site
Tenri, Nara, Japan
Research Site
Ginowan, Okinawa, Japan
Research Site
Habikino, Osaka, Japan
Research Site
Izumisano, Osaka, Japan
Research Site
Osakasayama, Osaka, Japan
Research Site
Sakai, Osaka, Japan
Research Site
Toyonaka, Osaka, Japan
Research Site
Tokyo, Ota, Japan
Research Site
Otsu, Shiga, Japan
Research Site
Sunto-gun, Shizuoka, Japan
Research Site
Bunkyo, Tokyo, Japan
Research Site
Bunkyo-ku, Tokyo, Japan
Research Site
Kiyose, Tokyo, Japan
Research Site
Minato-ku, Tokyo, Japan
Research Site
Mitaka, Tokyo, Japan
Research Site
Shinjuku, Tokyo, Japan
Research Site
Toshima-ku, Tokyo, Japan
Research Site
Fukuoka, Japan
Research Site
Gifu, Japan
Research Site
Hiroshima, Japan
Research Site
Kumamoto, Japan
Research Site
Kyoto, Japan
Research Site
Nagasaki, Japan
Research Site
Niigata, Japan
Research Site
Okayama, Japan
Research Site
Osaka, Japan
Research Site
Toyama, Japan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: AstraZeneca Japan Medical Director, MD AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00252759     History of Changes
Other Study ID Numbers: D791AL00002, V-15-33, OZV1533
Study First Received: November 14, 2005
Last Updated: January 27, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Lung Diseases, Interstitial
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 19, 2013